Monday, July 12, 2010

Pieces and Bits

I'm getting tired of titling posts "Bits and Pieces", so I cleverly changed things up this time around. Don't be too rattled, though, what follows is still a collection of MS related items that I thought you might find useful and/or interesting...

How effective are the CRAB (Copaxone, Rebif, Avonex, and Betaseron) drugs at slowing down the progression of disability in MS patients? Not very, according to some recently published studies. A paper analyzing these results has been making the rounds of the Internet forums for the past week (click here for paper), and the conclusion is that these widely prescribed and very expensive drugs do practically nothing to halt disability progression in the Multiple Sclerosis. The paper does a wonderful job at analyzing this very disappointing data, but I have to respectfully disagree with several of the conclusions it draws from this information. Written by Ashton Embry, who administers the excellent alternative MS site "Direct-MS" (click here) which contains very good information on the role of nutrition in the battle against MS, the paper draws the conclusion that the CRAB drugs are no better than snake oil in treating MS. While the new data suggests that these drugs don't stop the inexorable march of disability in MS patients, the drugs have been shown in clinical studies to cut down on the number of relapses and enhancing lesions (as seen in MRIs) experienced by the MS patients taking them. When these drugs were first approved, the assumption was that a reduction in relapse rate and lesion load would translate into a significant delay in disease progression. While it is a crushing disappointment that the CRABs most likely do not slow progression, to say they are worthless overstates things a bit. The fact is, they do reduce relapse rates for some taking them, which does improve the quality of life for patients with Relapsing Remitting Multiple Sclerosis. Although an improvement in quality of life might be less than what was hoped for, it is still of considerable benefit to those afflicted with the disease. Certainly, the drugs have been overhyped, and overpriced, but patients who had been experiencing four or five relapses a year before being put on one of the CRABs, and only one or two after, would argue that their taking the drug has not been without value.

The fact that research is now showing the CRAB drugs to be of limited, if any, value in halting or even delaying disease progression points to the abject failure of putting MS into a box marked "autoimmune". Countless millions of dollars have been spent developing and marketing these drugs, and billions upon billions of dollars have been made selling them to the captive audience that is the Multiple Sclerosis patient population. The CRAB drugs have been a tremendous boon both to pharmaceutical companies and to the practices of MS specialists, but this latest data highlights the fact that they are only sophisticated mechanisms for symptom management, and that the years spent searching for compounds to better tinker with the human immune system have taken the eye of medical research off of its rightful target, which should have been the search for the root cause of the autoimmune reaction. The concept of autoimmunity has managed to turn MS into a multibillion dollar a year industry, and yes, the drugs that have been developed with that concept in mind have been of some relief to some MS patients. One can only imagine, though, that if the same time, money, and energy had been put into searching for that which causes our immune systems to go awry, we'd be much farther along in our quest for a cure to the scourge that we call MS.

Let me state unequivocally that I am a CCSVI advocate who believes that the hypothesis should be researched as vigorously and as quickly as possible. The recent data regarding the ineffectiveness of the CRAB drugs in combating disease progression makes CCSVI research all the more imperative, and should fuel the clamor of MS patients worldwide to have their voices heard. We need treatment studies, and we need them now. If such studies should by chance disprove the CCSVI hypothesis, then so be it. At least the effort will have been expended in a noble effort to free MS patients from their disease, rather than consign them to a lifetime of indentured servitude to drugs of only marginal effectiveness.

MS is a notoriously hard disease to diagnose, the diagnostic process being one of exclusion, meaning that other possible conditions must be ruled out before a firm diagnosis of MS can be established. My own diagnosis has been seriously called into question, and there is disagreement between the doctors who have examined me at the National Institutes of Health and my personal neurologist over just what it is that is slowly crippling me. I've been questioning my diagnosis almost from the day I received it; my symptoms and disease course just didn't seem to match what I'd read about Primary Progressive Multiple Sclerosis and the experiences of others suffering from the disease. Studies have shown that between 5% -15% of those diagnosed with Multiple Sclerosis have been misdiagnosed, and are actually suffering from some other illness. Here's a paper (click here) that details the conditions that can be mistaken for MS, and includes a list of 100 such diseases. It's easy to make yourself crazy with information such as this (and believe me, I speak from experience), so be careful not to let this create doubt where there should be none, but if you have serious questions regarding your diagnosis, this paper is an invaluable resource. Knowledge is power, but be sure to wield it wisely.

Multiple Sclerosis Dreams (click here for website) is a new organization designed to bring hope and excitement to patients living with MS. Similar to the Make a Wish Foundation, MS Dreams is a nonprofit organization that will be granting the dreams and wishes of desperate and needy MS sufferers of any age. Such dreams might include sending them on the vacation a lifetime, meeting someone they've found inspirational, or supplying them with much-needed treatments or devices. The organization will be in the running for a "Pepsi Refresh" grant of $25,000, which you can help them achieve by voting for MS dreams once the internet polls open on August 1. Although a new organization, its organizers seem extremely sincere and devoted, and I wish them the best of luck in launching their endeavor. So, please visit their website, and vote early and vote often...

Researchers at UCLA have found a possible physiological cause for the depression often suffered by MS patients (click here for info). As if dealing with MS and its associated crap isn't depressing enough, it now appears that the disease causes atrophy of the hippocampus, a region of the brain closely associated with depression. MRIs have revealed that MS causes gray matter atrophy in general, so I suppose findings like this shouldn't be all that unexpected. A more momentous finding would be identifying what causes such atrophy, and may I suggest that decreased blood flow through the brain, such as might be seen in a vascular condition like, say, CCSVI, might be a pretty good candidate.

Of course, zombies also have an appetite for gray matter, but I don't think I've ever seen a paper linking zombies with depression or MS. As a matter of fact, a good zombie movie often cheers me up, so I'm willing to go on record right here and right now stating that zombies do not cause MS. Then again, no zombie flick I've ever seen really identifies exactly what causes zombie-ism, so I guess it can’t be ruled out that MS causes zombies. So be careful during your next visit to the neurologist's office, you never know when one of your fellow patients may try to take a bite out of you.

Well, not the most uplifting collection of information I've ever presented, so let me leave you all with cheerfully healing thoughts of puppy dogs, rainbows, pretty ponies, and...

22 comments:

thank you, thank you, thank you! Diag 2001 w/rrms, at age 48. I have been on Avonex, Rebif, Tysarbi, Novantrone & am curr on Copaxone along with Ampyra (2 months). I am now 57 yrs old w/spms. Relapses have never been an issue w/me; slow progression has. I "retired" from working 12/2006 and I now use a scooter 24/7, as I can no longer stand/walk or balance myself. Have any of the CRAB drugs helped me? I would say NO and as you call them they are snake oil! I think they are a waste of time, for me anyway. I saw my doc on 7/9 & told him I will probably discontine the ampyra as i see no benefit from it & i am seriously considering the same w/copaxone....he also said that by age 65 I should have "peaked" w/my progression & shouldn't need to continue taking any of the CRABS.....EWWW. If I don't take them what else (more) could happen? to me, continuing to take these drugs are a waste of time & money.....big money! For me the cost is minimal ($9 per 30 day supply thanks to my husbands military career) but ultimately I AM paying for this expensive treatment. I do think that CCSVI is certainly worth the exploration; if it does prove to be benificial great, if it's a dud at least it was an avenue traveled! Keep up with the info....I really enjoy reading your posts as nothing is ever sugar coated but always informative! Kim

It really is unfortunate that research shows the CRABS as ineffective. Mentally they provide a crutch and give me the impression that i am at least doing something to slow the progression. Unfortunately as a "liberation loser" the CRAB has been the only means of therapy. IF this research stands true it is really just another nail in the coffin. When all else fails and the day has been a bear believe it or not it actually is a relief when i take that copaxone shot. I guess at this point its back to "now what." The world is dragging its ass on the CCSVI theory and should the science of the CRABS be ineffective then as you say I will go from spms to zombie-ms. Did I metion MS sucks?Greek

How do you know zombies don't cause MS, don't you need a double blind controlled study to say that?

So we round up a bunch of zombies put them in contact with healthy non-MS'rs. For the control group, they would be in contact with zombie look alikes. We could sudy the outcomes for 5+ years and then determine the outcome. We would certainly want to be able to rule out any placebo affect that the zombies had on test subjects short term.

Another nit to pick with Embry's article is that his criticism of Veugelers study isn't mathematically correct. Embry states, "Because the 95% confidence intervals of the two findings overlap, this means thereis no real statistical difference between the two results." But this is wrong. Values with statistically significant differences *can* have overlapping confidence intervals. Statistical significance requires that the confidence interval of the *difference* does not include 0, which isn't quite the same thing. For an explanation, see http://www.cscu.cornell.edu/news/statnews/stnews73.pdf

I don't need a "Make a Wish" for MS patients...I need pain relief...and fear relief...this disease sucks in it's unpredictibility. I never can predict when the symptoms are going to take me down. So how can I work? Volunteer? Play? Planning for my life is the difficult part of this.As for the CRABS, I haven't had much progression lesion-wise since I started Copaxone. Symptom-wise, it's a different story. I'm getting to the point where I don't care about studies, etc. I just want relief. Period.

it is so hard to put my thoughts in order since my MS DX, and, man, am I tired of these abbreviations, and then my HUSBAND left meokay, not husband; boyfriend, but his whole family AND HEalways thought I was like a wife to him!

Like a wife, but what, DNA slightly closer to the Orangutan?

why did I come here? oh, Thank you, big pull back from the ledge, so to speak...

Marc, thanks, as always, for a very informative and well-written post.

The other day, I happened to also read Ashton Embry’s paper about the CRAB drugs and was greatly disheartened by the research and his analysis. I have been on Copaxone now for 18 months, and while the first 6 months were a roller coaster ride of exacerbations, I now feel that I have stabilized somewhat. I don’t know if it is the medicine or my “vitamin D therapy” or just happenchance. But I certainly don’t want to stop to find out…

Which leads me to a point regarding a recent study published by Teva in the journal “Multiple Sclerosis”. Teva followed a group of 100 RRMS patients taking Copaxone starting in 1991 and over a 15 year time period (now to be extended to 20 years). While this is a small number and there were no comparisons to an untreated “control group”, the study did show a reduction in the rate of disease progression. Specifically, while the patients in the study had a mean disease duration of 22 years, only 35% had transitioned over to SPMS. These statistics compare favorably to the 65% of those with RRMS who will transition to SPMS after an average of 19 years with the disease (taken from Wikipeida). In addition, the study showed that after the 15 years, 80% of the group still walked unaided, which would indicate an EDSS of less than 6.0. Dr. Embry quotes statistics from the Veugelers study that patients on average reached 6.0 after a range of 14.4 years (untreated) to 18.6 years (treated). At 22 years, only 20% of the Teva study participants had reached an EDSS of 6.0. http://www.pipelinereview.com/index.php/2010022532814/Proteins-and-Peptides/Copaxone-15-Year-Study-in-Multiple-Sclerosis-Patients-Demonstrates-Robust-Long-Term-Efficacy-and-Safety.html

This study was small and published by the company that produces the drug (albeit in a peer reviewed journal). However, I believe it gives some positive results that should not be discounted. Believe me, the day I have the opportunity to be checked/treated for CCSVI I will run (OK maybe figuratively) to get it done. But in the meantime, we have to use the tools that we have…

Totally off topic, but it's 3 in the morning and I can't fall asleep so I hit my MS blogs list and of course came across your latest post which somehow resulted in my reading your blog from its very first post and ... take a breath here ... I have to say you are a first among equals. You are an excellent writer; no, make that brilliant. Okay, having gotten that off my chest I'm off to attempt sleep again.Judy

"Zombies, zombies, zombies." HA Yes Marc, it is fun to say. I can't wait to [some day] get voice recognition software. You should have seen, or perhaps I should have left, the misspelled versions of what I typed. I type so poorly these days 9keeping in mind that I never was spectacular at it), I can't help but wonder if it my MS playing tricks with my fingers.

Thanks for your pieces and bits. When Medicare finally approved coverage of Betaseron in the mid-late 90's, I took it for a year, then stopped for a year when Medicare stopped coverage, then started again after coverage returned, for another year. In those three years I went from a history of having 1 relapse/3 years since 1983 to having 2/3 relapses one year!

I progressed to SPMS status, then started Copaxone, because obviously the interferon didn't work. In the last three years I've had 2 relapses. While technically I am still on the Copaxone, my compliance has gone 'round the bend.

A long time ago, when I asked a neurologist for an antidepressant, he told me unequivocally that there was no connection between depression and MS.

A year later, when I switched to my current neurologist, who is also an MS 'specialist', said that "he could not imagine that any disease of the CNS (i.e. the brain) as MS is, wouldn't affect affect," i.e. cause depression. Fortunately, I've not had any problems since being on Zoloft.

I have been tring to make an appt w/an interI nists & i was told that because of the 21% cuts to medicare (my primary) and tri-care (my secondary) that no new medicare OR tricare patients would be seen! have been on the phone all AM trying to find one! i guess this is part of the healthcare reform fall-out!kim

Thank you Marc. I only recently have found your blog. It is the best one on MS that I've seen so far. I've known or suspected based on my reading of the medical literature that the CRAB drugs are not that effective. For me, the side effects were worse, so after 2 years on Copaxone I stopped taking it in Oct 2009. As a scientist, I decided that I MUST do my own control. There have been no changes in my condition. I don't buy the dogma that not taking the drugs "might" cause great disability at some unexpected time. Based on my read of the literature, you can still be on the drugs and suffer many, many setbacks.

There seems to be a lot of conflicting information on the usefulness of the drugs but even if they work as well as the most positive studies suggest, they just don't seem to be good enough, not taking into account the horrible, immediate side-effects and the potential that there may be unknown long term side effects. Of course, they were developed on that mouse model with the fake MS so I suppose it isn't surprising that they don't really work.

I've read the research accomplishments section on the MS Society (Canada) website and I always come away thinking, "That's it?". One of the accomplishments of the 7 listed is that research has shown that MS is a costly disease. Gosh.

Of course, before the CCSVI special on W5 last November, I knew almost nothing about MS. I knew it could cause trouble walking and then every once in a while there'd be an article in the paper about how a there was a great new treatment or some other defining new research. From that, I had assumed that the drug therapies were generally pretty good and while the treatment wasn't perfect, the forward steps being made were epic.

I've learned a lot and I don't see anything done to date that has been epic in the treatment of MS except CCSVI. True, there isn't realms of research on it yet but what there is makes the existing list of 7 look pretty thin.

Now that's a thought. Next time someone asks why I lurch when I walk, I'll respond "Zombie! Zombie! Zombie!" and gnash my teeth.

Having gone from benign to SP I missed out on my chance for CRABs (that sounds naughty), and I'm glad I did. When I took drugs for my asthma I was taking half the pediatric dose and still got the shakes.

What are your thoughts on Fingolimod, the first oral medication for MS that looks like it will be approved this fall? What I find so fascinating about this medication is its history in Chinese medicine. It really makes you pause when considering pumping artificial agents into your system, which many of us do daily, weekly or monthly.

There's so much going on right now, I can't help but wonder if the CCSVI outrage prompted this onslaught of newly published information. I think we're at the cusp of something big in terms of treating MS. Some might find this wishful thinking, but I'm an optimist!

Marc, They couldn't have picked a better person to represent those of us with MS for the telecast. You are more knowledgeable, about this subject, than anyone else I have encountered including all of the Neurologist I have talked with. With your passion for life and your determination to not let MS define who you are, how could anyone be better? Keep smiling. Thank you for all you do!Eddie

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Regretfully, due to the high volume of e-mail received and the realities of living with progressive MS, I'll no longer be able to respond to all e-mails sent. I do read each note, and will do my best to answer as many messages as I can.

About Me

I'm Marc, a 53-year-old male, living in New York City with my lovely and wonderful wife Karen. Diagnosed with Primary Progressive Multiple Sclerosis in March of 2003, I now require a wheelchair to get around the city. I like to drive the wheelchair at full speed, thus the moniker "Wheelchair Kamikaze". I've managed to rig a camera to my chair, so I'm able to take videos and still photos from the unique vantage point of a wheelchair, which I intend to post here.
Before getting sick, I was the Director of DVD Production for one of the major international music companies. Yes, I was once a member of the Evil Empire...
Prior to my enlistment in the Evil Empire, I worked as a video producer and editor.
I grew up in New York City, and spent the 1980s in Boston (college and postcollege rock 'n roll craziness). During the 1990s, I lived in South Florida, until I woke up one morning and realized I was living in South Florida, came to my senses, and moved back to New York.
I hope you like my blog...